System for medical lead tunneling

ABSTRACT

An apparatus includes an elongated tube and an elongated rod having a holding member on one end, the holding member is adapted to hold an end of a lead such that the end of the lead can be pulled through the elongated tube resulting in minimal forces on the lead.

FIELD OF THE INVENTION

[0001] This invention relates to the field of medical devices, and morespecifically to a method and apparatus for medical lead tunneling.

BACKGROUND

[0002] Medical leads, such as cardiac leads, have a distal end havingone or more electrodes and a proximal end having a terminal which iscoupled to a pulse generator. Sometimes, subcutaneous tunneling isrequired to implant the lead. For example, subcutaneous tunneling of thelead can be needed during implantation of epicardial leads, nerve ormuscle stimulation leads, or cardiac leads with the pulse generatorimplanted abdominally. Subcutaneous tunneling is done using a tunnelingtool which includes an elongated rod that is inserted through thesubcutaneous tissue. After the rod is inserted, a lead terminal holderis attached to the tip of the rod and the lead terminal is attached tothe terminal holder. Then the rod is pulled back through thesubcutaneous tissue to bring the lead terminal through the tissue to thepulse generator. Subcutaneous lead tunneling can result in high forceson the lead as it is being pulled through the subcutaneous tissue.

SUMMARY

[0003] An apparatus includes an elongated tube and an elongated rodhaving a holding member on one end, the holding member is adapted tohold an end of a lead such that the lead can be pulled through theelongated tube resulting in minimal forces on the lead.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004]FIG. 1 shows a side view of a tube in accordance with oneembodiment.

[0005]FIG. 2 shows a side view of the tube of FIG. 1 mounted to atunneling tool.

[0006]FIG. 3 shows a lead being pulled through the tube of FIG. 1.

[0007]FIG. 4 shows a tube according to one embodiment.

[0008]FIG. 5 shows an implanted pulse generator and a lead implantedsubcutaneously in accordance with one embodiment.

DETAILED DESCRIPTION

[0009] In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that other embodiments may be utilized and that structuralchanges may be made without departing from the scope of the presentinvention. Therefore, the following detailed description is not to betaken in a limiting sense, and the scope of the present invention isdefined by the appended claims and their equivalents.

[0010] In some embodiments, the present system provides a lead tunnelingmethod and system that allows, for example, subcutaneous lead tunnelingfor a cardiac pacing or defibrillation lead. In one example, the systemcan be used to transport a lead subcutaneously from a lead entrancepoint to a pulse generator implanting site. The lead tunneling systemassists in preventing damage to the lead and electrode in the tunnelingprocedure as the force placed on the lead and electrode is minimized oreliminated.

[0011]FIG. 1 shows a side view of a tube 10 used for subcutaneoustunneling, according to one embodiment. Tube 10 includes an elongated,hollow body 12 extending from a first end 14 to a second end 16. Tube 10is a generally cylindrical tube including an inner bore 18. Tube 10 canbe flexible or rigid and can be made of plastic, polymer, Teflon, ametal, such as stainless steel, or a composite material of metal andpolymer. In some embodiments, the inside of the tube can be coated toprovide less friction. For example, at least a portion of the innersurface of tube 10 can be coated with polyethylene glycol, Teflon, Dow360 Medical Fluid, or a silicone lubricant. Other examples include alubricious coating applied by secondary processing such as wetchemistry, plasma deposition, or vapor deposition, for example. Whenmounted or inserted subcutaneously within a body, tube 10 provides asubcutaneous tunneling path defined by bore 18. This allows an end of alead to be pulled from first end 14 through the tube and out of secondend 16 without undue force being placed on the lead.

[0012]FIG. 2 shows tube 10 mounted on a tunneling device 20. Tunnelingdevice 20 is used to insert tube 10 subcutaneously within a patient.Tunneling device 20 includes a rigid, elongated rod 22 extending from afirst end 24 to a second end 26. A tip 28 is mounted to first end 24 anda handle 30 is mounted to second end 26. Tip 28 is for driving thetunneling device through subcutaneous tissue by pushing on handle 30. Inone embodiment, tip 28 includes a blunt, cone-shape. In one example, tip28 is removably mounted to first end 24, by using a threaded attachment,for example. Handle 30 can also be removably attachable to second end 26using a threaded attachment, for example. The length and diameter of rod22 can vary depending on the tunneling procedure being done. Thetunneling rod 22 is stiff enough to tunnel subcutaneously and, in someexamples, can have flexibility to facilitate the curvature of regions ofthe body where lead tunneling is to be performed. In one embodiment, atunneling device, such as a Model 6888 Lead Tunneler, by Guidant, can beused.

[0013] Tube 10 fits over rod 22 such that rod 22 extends through bore 18from one end of tube 10 to the other. To place tube 10 onto tunnelingdevice 20, either handle 30 or tip 28 can be removed from its respectiveend, and the tube is slid over rod 22. The tip or handle is thenreattached to the rod.

[0014] To insert tube 10 subcutaneously, tube 10 is placed onto rod 22.Tip 28 is pushed into and through the tissue until the tip exits thetissue at the proper point. When the tube is properly placed, tip 28 orhandle 30 can be removed from rod 22 and the rod can be pulled out oftube 10, which then defines a subcutaneous tunnel.

[0015]FIG. 3 shows a lead 50 before being pulled through tube 10, inaccordance with one embodiment. Tube 10 is inserted within body 51 anddefines a subcutaneous tunnel through bore 18. Lead 50 is pulled throughtube 10 using a lead carrier tool 52. In one embodiment, lead carriertool 52 includes an elongated body 54 extending from a first end 56 to asecond end 58. Elongated body 54 can include a rigid rod or a wire.Second end 58 can include a handle 60. First end 56 includes a leadholding member, such as a gripping member 62 which is adapted to gripand hold an end of lead 50. In one embodiment, gripping member 62 caninclude a biased clip 63 to provide a gripping force to the outersurfaces of lead terminal 53. In other embodiments, the lead holdingmember can include spring-biased clips, clamps, or other gripping orholding members.

[0016] In one embodiment, rod 22 of tunneling device 20 (FIG. 2) can beused as the lead carrier tool 52. For example tip 28 can be removed fromrod 22 (FIG. 2) and a holding member, such as member 62, can be attachedin its place.

[0017] Referring to FIGS. 1-3, in one example use the present tunnelingsystem can include inserting elongated tube 10 subcutaneously within abody and pulling a lead through the elongated tube. For example, a userchooses an appropriate diameter size tunneling device 20 and tube 10.Tube 10 is mounted to rod 22 and the handle and tip are screwed onto thetunneling device 20. In one embodiment, the tunneling device is tunneledfrom the lead sight to the pulse generator sight subcutaneously. In someembodiments, the rod can be tunneled from the pulse generator sight tothe lead sight. After the device has been tunneled, either the tip orthe handle can be unscrewed and the rod can be withdrawn from tube 10.An end of the lead, either the terminal end or the electrode end, isengaged to the holding member 62, which is attached to the lead carriertool 52 (which can be the tunneling rod 22 or a separate member). Thecarrier tool 52 is inserted into tube 10 and then pulled through thetube to pull the end of the lead through the tube from one end of thetube to the other. The lead is disengaged from holding member 62 andtube 10 is removed from the patient. The lead is then plugged into apulse generator. This system minimizes or eliminates tunneling forces onthe lead without complicating subcutaneous implantation.

[0018]FIG. 4 shows a partial perspective view of a tube 70 in accordancewith one embodiment. Tube 70 includes an elongate, hollow body extendingfrom a first end 72 to a second end 74 and includes an internal bore 76.Tube 70 includes a peel-away structure allowing the tube to be splitafter being inserted subcutaneously. For example, one embodimentincludes one or more tabs 78, 80 extending from the tube. One embodimentincludes one or more scored or weakened sections 82 runninglongitudinally along the tube body. In use, tube 70 can be insertedsubcutaneously as discussed above. After a lead has been pulled throughthe tube, tabs 78 and 80 can be grabbed and pulled apart to split thetube body to remove the tube. Such a peel-away structure is useful, forexample, if a portion of the lead (for example a terminal) is largerthan the bore of the tube. Accordingly, in one example the lead can bepulled through the tube by the electrode end from end 74 to end 72 withthe larger terminal end remaining outside end 74. The tabs 78, 80 arethen pulled apart to split the tube and the tube is removed.

[0019]FIG. 5 illustrates one of the applications for the present system.For example, one application includes an implantable pulse generator 90such as a pacemaker, defibrillator or a cardiac resynchronizationtherapy device. The pulse generator 90 is coupled with a lead system 92.The lead system 92 extends subcutaneously from heart 93 to pulsegenerator 90. In this example lead 92 is an epicardial lead. Pulsegenerator 90 can include circuitry such as monitoring circuitry andtherapy circuitry. The circuitry is designed to monitor heart activitythrough one or more of the leads of the lead system. The therapycircuitry can deliver a pulse of energy through one or more of the leadsof lead system to the heart, where the medical device 90 operatesaccording to well known and understood principles.

[0020] In other examples, the present system allows for subcutaneousimplantation for when implanting a lead/electrode for nerve and musclestimulation. Other embodiments can be used with epicardial leadplacement and for myocardial lead placement with the pulse generatorabdominally implanted or pectorally implanted. In other embodiments thedevice can be applicable for sub-muscular or intra-muscular tunneling,or other tunneling through a structure in the body that must betraversed in order to implant a lead.

[0021] The present system allows for tunneling leads subcutaneouslywithout imposing undue force on the lead. For example, in oneembodiment, the present system protects the lead from damage since thelead is tunneled with reduced or minimal force through the tunnelingtube, instead of tunneling directly through the subcutaneous area.

[0022] It is understood that the above description is intended to beillustrative, and not restrictive. Many other embodiments will beapparent to those of skill in the art upon reviewing the abovedescription. The scope of the invention should, therefore, be determinedwith reference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

What is claimed is:
 1. An apparatus comprising: an elongated tube; andan elongated rod having a holding member on one end and dimensioned tofit within the elongated tube, the holding member adapted to hold an endof a lead such that the end of the lead can be pulled through theelongated tube.
 2. The apparatus of claim 1, wherein the holding memberis removably attachable to the elongated rod.
 3. The apparatus of claim1, wherein the elongated tube is flexible.
 4. The apparatus of claim 1,wherein the elongated tube is rigid.
 5. The apparatus of claim 1,wherein the elongated tube has an internal bore diameter larger than thelead diameter.
 6. The apparatus of claim 1, wherein the elongated tubeincludes a peel-away structure.
 7. The apparatus of claim 1, wherein theelongated tube includes a coated internal surface.
 8. The apparatus ofclaim 1, wherein the holding member is adapted to grip a terminal end ofthe lead.
 9. The apparatus of claim 1, wherein the holding member isadapted to grip an electrode end of the lead.
 10. The apparatus of claim1, wherein the holding member includes a biasing portion to engage anouter surface of the lead.
 11. A subcutaneous tunneling systemcomprising: an elongated tube; a tunneling rod extending from a handleend to a tip end, wherein the elongated tube is mountable around thetunneling rod, the tunneling rod for inserting the elongated tubesubcutaneously; and a holding member adapted to hold an end of a lead topull the lead through the elongated tube.
 12. The system of claim 11,wherein the holding member is removably attachable to the tip end of thetunneling rod.
 13. The system of claim 11, further comprising aelongated lead carrier, wherein the holding member is attached to an endof the elongated lead carrier.
 14. The system of claim 11, wherein theelongated tube is flexible.
 15. The system of claim 11, wherein theelongated tube is rigid.
 16. The system of claim 11, wherein theelongated tube includes a peel-away structure.
 17. The system of claim11, wherein the elongated tube includes an internal bore having adiameter dimensioned to be larger than a diameter of the lead.
 18. Anapparatus comprising: an elongated rod having a holding member on oneend the holding member adapted to hold an end of a lead; and means forminimizing tunneling forces on the lead as the lead is pulled through asubcutaneous portion of a body by the holding member.
 19. The apparatusof claim 18, wherein the means includes an elongated, hollow tubeinserted subcutaneously into the body.
 20. The apparatus of claim 18,wherein the holding member is adapted to grip a terminal of the lead.21. The apparatus of claim 18, wherein the holding member is adapted togrip an electrode end of the lead.
 22. An apparatus comprising: anelongated, hollow tube having an inner bore diameter dimensioned to belarger than an outer diameter of a lead, the elongated hollow tube forproviding a tunnel within a body; and an elongated rod having a leadholding member on one end and a handle on a second end, the elongatedrod dimensioned to fit within the elongated tube such that the leadholding member extends from a first end of the elongated tube and thehandle extends from a second end of the elongated tube, the lead holdingmember adapted to hold an end of the lead located outside the first endof the elongated tube such that the end of the lead can be pulledthrough the elongated tube to exit on the second end of the elongatedtube.
 23. The apparatus of claim 22, wherein the elongated tube isflexible.
 24. The apparatus of claim 22, wherein the elongated tube isrigid.
 25. The apparatus of claim 22, wherein the elongated tubeincludes a peel-away structure.
 26. A method comprising: inserting anelongated tube subcutaneously within a body; and pulling an end of alead through the elongated tube.
 27. The method of claim 26, whereininserting the elongated tube includes mounting the elongated tube arounda tunneling tool, inserting the tunneling tool through subcutaneoustissue, and removing the tunneling too such that the elongated tuberemains in the subcutaneous tissue.
 28. The method of claim 26, whereinpulling the lead through the elongated tube includes inserting anelongated rod through the elongated tube, the elongated rod having afirst end and a second end, the second end having a holding member,attaching the holding member to an end of the lead and pulling the firstend of the elongated rod to pull the lead through the elongated tube.